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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromyograph, Diagnostic
510(k) Number K944787
Device Name INTEGRATED MOVEMENT ANALYZER
Applicant
Maryrose
5530 Corbin Ave.
Suite #315
Tarzana,  CA  91356
Applicant Contact MARYROSE CUSIMANO
Correspondent
Maryrose
5530 Corbin Ave.
Suite #315
Tarzana,  CA  91356
Correspondent Contact MARYROSE CUSIMANO
Regulation Number890.1375
Classification Product Code
IKN  
Subsequent Product Codes
ISD   KQX  
Date Received09/28/1994
Decision Date 07/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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